Cleared Traditional

K822470 - PSI INORGANIC PHOSPHORUS

K822470 is the FDA 510(k) clearance for PSI INORGANIC PHOSPHORUS by Pointe Scientific, Inc.,. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K822470 · Pointe Scientific, Inc., · Chemistry device
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Sep 1982
Decision
28d
Days
Class 1
Risk

K822470 is an FDA 510(k) clearance for the PSI INORGANIC PHOSPHORUS. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pointe Scientific, Inc., devices

Submission Details

510(k) Number K822470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1982
Decision Date September 14, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

All 73
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K822470.
PHOSPHORUS REAGENT SYSTEM
K840215 · Sclavo, Inc. · Mar 1984
PARAMAX PHOSPHORUS REAGENT
K833002 · American Dade · Oct 1983
COBAS REAGENT FOR INORGANIC PHOSPHORUS
K823580 · Hoffmann-La Roche, Inc. · Jan 1983
KING DIAGNOSTICS PHOSPHORUS TEST
K811749 · King Diagnostics, Inc. · Jul 1981
ELVI INORGANIC PHOSPHOROUS
K792401 · Volu Sol Medical Industries · Dec 1979
INORGANIC PHOSPHORUS REAGENT
K791708 · Gilford Diagnostics · Sep 1979